FDA Enforcement
Class II
Ongoing
Centurion OB INSTRUMENT TRAY, REF MN3925; Medical procedure convenience tray
Recall: Z-1917-2024
·
Reported June 5, 2024
Enforcement
- Recall Number
- Z-1917-2024
- Event ID
- 94448
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- MEDLINE INDUSTRIES, LP - Northfield
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- June 5, 2024
- Initiation Date
- March 1, 2024
- Classification Date
- May 29, 2024
- Address
- 3 Lakes Dr, Northfield, IL, 60093-2753, United States
Description
Centurion OB INSTRUMENT TRAY, REF MN3925; Medical procedure convenience tray
Reason
Trumpet Needle Guide ring can detach when excessive pressure is applied.
Code Info
UDI/DI 40653160122945 (case), 10653160122944 (unit), Lot Numbers: 23JBX257, 23KMG455
Distribution
US Nationwide distribution.
Quantity
30 units